Phase 2
Completed N=16
Vaccine Therapy in Preventing Cervical Cancer in Patients With Cervical Intraepithelial Neoplasia
Cervical Cancer · Precancerous Condition
Source: ClinicalTrials.gov NCT00121173 ↗
Enrolled (actual)
16
Serious AEs
0.0%
Results posted
Jul 2018
Primary outcomePrimary: Safety and Toxicity — 0; 0; 0 Participants
Summary
RATIONALE: Vaccines made from protein and DNA may help the body build an effective immune response to kill abnormal cells in the cervix. The use of vaccine therapy may prevent cervical cancer.
PURPOSE: This phase I/II trial is studying the side effects and best dose of vaccine therapy and to see how well it works in preventing cervical cancer in patients with cervical intraepithelial neoplasia and human papillomavirus.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Safety and Toxicity |
0; 0; 0 | — |
| PRIMARY Efficacy |
0; 0; 3 | — |
| SECONDARY Regression of CIN3 Lesions |
0; 0; 3 | — |
| SECONDARY Number of Participants With T-cell Immune Responses in the Blood |
0; 0; 0 | — |
| SECONDARY Number of Participants With Correlated Measures of Immune Response With Clinical Response |
0; 0; 0 | — |
| SECONDARY Number of Participants With Correlated Measures of Immune Responses With the Preclinical Model |
0; 0; 0 | — |
Eligibility Criteria
DISEASE CHARACTERISTICS:
- Histologically confirmed cervical intraepithelial neoplasia (CIN2/3)
- Human papillomavirus-16-positive disease
PATIENT CHARACTERISTICS:
- Age: > 18
Other
- Not pregnant
- Immunocompetent
Data sourced from ClinicalTrials.gov (NCT00121173). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.